Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T

PRIMARY OBJECTIVES:

I. To assess whether radiation therapy (RT) increases the immunogenic potential or
sipuleucel-T in participants with castration recurrent prostate cancer.

II. To assess systemic changes to the immune system and genetic changes to immune cells in
participants treated by the combination of RT and sipuleucel-T.

III. To assess the induction of antigen-specific immune responses to prostatic acid
phosphatase (PAP), cancer/testis antigen 1B (NY-ESO-1) and antigens that have proven to be
released by radiation (such as, heat shock protein 90 [HSP-90], calreticulin, etc.).

SECONDARY OBJECTIVES:

I. To assess adverse event rates in participants receiving the high-dose radiation and
sipuleucel-T therapy.

II. To assess prostate-specific antigen (PSA) changes. III. To assess overall and cancer
specific survival.

OUTLINE:

Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the
first sipuleucel-T dose.

After completion of study treatment, patients are followed up at 3 and 6 months and then
annually thereafter.

Inclusion Criteria:

- Have minimally symptomatic metastatic castration recurrent prostate cancer with bone
lesions; this patient population is defined as having failed hormone treatment and has
insurance approval for PROVENGE® therapy

- Patients that have been prescribed sipuleucel-T and have not started treatment

- Must be candidates for radiation treatment to bone lesions

- Patient or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study

- Patients who have received prior radiation of osseous lesions

- Patients who have received any prior immunotherapy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Unwilling or unable to follow protocol requirements

- Any condition which in the investigator's opinion deems the patient an unsuitable
candidate